Label: ROSACEA FREE (pine needle oil- pinus sylvestris sambucus nigra flower calendula officinalis flower abies balsamea leaf oil echinacea angustifolia salve

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 19, 2021

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    PINUS SILVESTRIS (1X) HPUS (PINE RESIN)

    SAMBUCUS NIGRA (2X) HPUS (ELDERBERRY)

    ORG. CALENDULA OFFICINALIS (2X) HPUS (MARIGOLD)

    ABIES BALSAMEA (2X) HPUS (BALSAM FIR)

    ECHINACEA ANGUSTIFOLIA (6X) HPUS

  • PURPOSE

    PROPERTIES

    SKIN PROTECTANT

    ANTI-INFLAMMATORY

    SKIN PROTECTANT

    SKIN PROTECTANT

    MULTI-PURPOSE SKIN HEALING REMEDY

  • INDICATIONS & USAGE

    USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH EXTREMELY DRY, DAMAGED, INFLAMED OR AGING SKIN.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: APPLY TO CLEAN, DRY AFFECTED AREA MORNING AND NIGHT, AS NEEDED UNTIL CONDITION CLEARS. THEN APPLY NIGHTLY TO MAINTAIN HEALTHY SKIN.

  • INACTIVE INGREDIENT

    OTHER INGREDIENTS: ORGANIC BEESWAX, ORGANIC OLIVE OIL, ORGANIC ARGAN OIL, ORGANIC SEA BUCKTHORN OIL

  • WARNINGS

    WARNING: TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN FIRST. DO NOT USE IF ALLERGIC TO OR HYPER-SENSITIVE TO ANY INGREDIENT IN THIS SALVE. IF CONDITION PERSISTS OR WORSENS CONSULT YOUR HEALTH CARE PROVIDER. (* = CERTIFIED ORGANIC INGREDIENTS)

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • QUESTIONS

    CUSTOMER SERVICE 310-526-6108

  • OTHER SAFETY INFORMATION

    STORE IN A COOL DRY PLACE OR REFRIGERATE

  • PRINCIPAL DISPLAY PANEL

    rosacea 1 oz

  • INGREDIENTS AND APPEARANCE
    ROSACEA FREE 
    pine needle oil (pinus sylvestris) sambucus nigra flower calendula officinalis flower abies balsamea leaf oil echinacea angustifolia salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52810-602
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T) SAMBUCUS NIGRA FLOWER2 [hp_X]  in 100 mL
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER2 [hp_X]  in 100 mL
    PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) (PINE NEEDLE OIL (PINUS SYLVESTRIS) - UNII:5EXL5H740Y) PINE NEEDLE OIL (PINUS SYLVESTRIS)1 [hp_X]  in 100 mL
    ABIES BALSAMEA LEAF OIL (UNII: 2FGT9T2SQC) (ABIES BALSAMEA LEAF OIL - UNII:2FGT9T2SQC) ABIES BALSAMEA LEAF OIL2 [hp_X]  in 100 mL
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA6 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    HIPPOPHAE RHAMNOIDES WHOLE (UNII: YAA7TG74X6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52810-602-1130 mL in 1 JAR; Type 0: Not a Combination Product10/18/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/18/2012
    Labeler - PUREMEDY (003552251)
    Establishment
    NameAddressID/FEIBusiness Operations
    PUREMEDY003552251manufacture(52810-602)
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